- Nigel Rollins, scientist
Department of Maternal, Newborn, Child and Adolescent Health and Ageing, World Health Organization, Geneva, Switzerland
- rollinsn{at}who.int
Early infant feeding is critically important for the survival, development, and lifelong health of children. It is also a big business. In 2019, global sales of infant formula milks exceeded $55bn (£45bn; €51bn). Even during the global economic crisis of 2008-09, sales of commercial milk formulas increased 8-9% year on year.1 Parents want to give their children the best start in life and understand that how they feed their infants contributes to those early health and development outcomes. The formula milk industry understands this too.
The linked study by Cheung and colleagues (doi:10.1136/bmj-2022-071075) reports a survey conducted in 15 countries exploring the health and nutrition claims made in the marketing of infant formula products.2 The authors performed a systematic search of websites, examined packaging of formula products, and documented claims made about the formula product and citations of scientific evidence supporting those claims. The most common claims were that formula products support brain development, strengthen healthy immune systems, help growth and development, and are easy to digest.
According to the study, each product, across all formula types, was generally linked with two claims. Forty one types of ingredients were identified that had some health claim linked with them. Multiple health claims were associated with each type of ingredient; and multiple different ingredients were associated with each type of health or nutrition claim. In some cases, it was unclear which specific ingredient formed the basis for the claim.
Yet, the evidence to support claims for products or ingredients was not substantial and was of questionable scientific integrity. No scientific reference was provided for most products making specific health claims (74%). When references were provided, 56% reported findings of clinical trials while the rest were review articles, opinion pieces, cross sectional studies, or other types of research including animal studies. Examining the comparative trials referenced in support of 51 claims, 90% were deemed to have high risk of bias due to inappropriate exclusion of data from analyses, missing outcome data, or findings simply not supporting the claim. Furthermore, more than 80% of these trials had authors who either received formula industry funding or were directly affiliated with industry.
Some infant formula ingredients are deemed Generally Recognised as Safe (GRAS) by authorities such as the US Food and Drug Administration, and formula is widely regulated as a food. Authorities first consider the safety of substances with respect to their intended use but do not usually evaluate the validity of claims about beneficial outcomes. This contrasts with the more rigorous assessment of pharmaceuticals that includes safety but also evaluates effectiveness.
As seen in Cheung and colleagues’ study, the formula industry infers, suggests, and claims that its products benefit brain development, immunity, and growth in young infants. Remarkably, products that claim to influence critical physiological processes in this vulnerable population are not scrutinised for their actual, replicable effect. Ingredients such as polyunsaturated fatty acids and human milk oligosaccharides are present in breast milk and are unquestionably important in human systems biology. When these ingredients are added to infant formulas, manufacturers claim additional benefits and they are marketed as premium products and at higher prices. Yet, systematic reviews report that such added ingredients are not associated with added benefit and do not reduce the known health and development risks associated with using formula in place of breast milk.345 When formula packaging states that an ingredient “supports brain development” or improves immunity or growth, it is easy and reasonable for parents to believe that it will improve brain development, immunity, and growth more than products that do not have these ingredients. And they are willing to pay more. Ascribing special health properties to formula products also serves to narrow perceived benefits of breastfeeding.
The addition of ingredients that purport to offer additional benefit is also a matter of equity. If these products delivered on what they claim, then should this benefit be restricted only to infants of parents who can afford the more expensive formulas? Or should these formulas be standard, so that infants whose parents cannot afford the premium products are not further disadvantaged?
In a busy world, health professionals and families lack the time to properly scrutinise claims. Industry is unlikely to change its practice given shareholder interests. Self-regulation has not worked, and responsible, ethical marketing by the formula industry seems unlikely. Regulatory authorities must therefore decide whether the use of such apparently misleading evidence is acceptable or hold the formula industry to higher standards, require better products based on high quality evidence, and review standards. On the basis of this study, governments and regulatory authorities must commit the necessary time and attention to review the claims of formula milk products and the evidence provided and thereby protect infants and parents from commercial interests.
Footnotes
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Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The author declares the following other interests: NR is a member of The 2023 Lancet Breastfeeding Series Group and lead author of a paper about marketing of formula milk published as part of the The Lancet series.
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Further details of The BMJ policy on financial interests is here: https://www.bmj.com/sites/default/files/attachments/resources/2016/03/16-current-bmj-education-coi-form.pdf.
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Provenance and peer review: Commissioned; not externally peer reviewed.